View clinical trials related to Wet Macular Degeneration.
Filter by:Neovascular or wet age-related macular degeneration (nAMD) is a degenerative ocular disease associated with the infiltration of abnormal blood vessels in the retina from the underlying choroid layer and is a leading cause of blindness in patients over 65 years of age. The abnormal angiogenic process in nAMD is stimulated and modulated by vascular endothelial growth factor (VEGF). Treatment of nAMD requires frequent intravitreal (IVT) injections of VEGF inhibitors (anti-VEGF) administered every 4-16 weeks. ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product being developed for the treatment of nAMD and offers the potential for sustained intraocular expression of aflibercept following a single IVT injection. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.
This study is a randomized, multi-center, double blind, Lucentis controlled non-inferiority study in neovascular age-related macular degeneration patients. The objective of this study is to compare the efficacy and safety of TAB014 and ranibizumab (Lucentis).
The purpose of the Phase 1 study is comprised of single ascending-dose component (Part 1) and multiple ascending-dose component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKG712 in patients with neovascular age-related macular degeneration (nAMD).
The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.
The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and high concentration component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).
Age-related macular degeneration (AMD) is a complex eye disorder and the most common macular disease affecting millions of aged people in the developed countries, with an estimation that the number of AMD patients will be increased to 196 million in 2020, 288 million in 2040. Vision loss, central scotomas and metamorphopsia are the hallmark signs in patients with macular diseases. Metamorphopsia can be defined as a deformation of seen rectilinear lines due to photoreceptor separation/location and it is a typical but not exclusive sign of retinal disease. The most effective method of treating wet AMD is currently the anti-vascular endothelial growth factor intravitreal injections (anti-VEGF). A further concern is the enormous costs and restriction of human resources that make periodic imaging unfeasible. Therefore, in patients with AMD treated by intravitreal anti-VEGF, monitoring with sensitive psychophysical tools could advance the time for diagnosis of CNV reactivation and enhance the outcome of treatment. For assessment of the visual function, visual acuity and Amsler grid have been the gold standard. The Amsler grid is a simple and noninvasive test effortlessly understood by the patient, consisting of evenly spaced vertical and horizontal lines outlining 400 square, it has been widely adopted as a subjective test for metamorphopsia. However, it also produces high false-negative rate. Moreover, the answer to this test is dichotomous: straight or crooked lines and does not allow for quantification thus, it is problematic to monitor the visual function along the course and to evaluate the effectiveness of treatment with anti-VEGF agents. The M-chart (Inami Co., Tokyo, Japan) is a diagnostic device developed by Matsumoto to quantify the grade of metamorphopsia in patients with various types of macular diseases. The usefulness of M-charts has been already demonstrated in different retinal diseases from macular pucker to BRVO. The aim of this study is to compare the traditional Amsler grid and the M-Charts in evaluating metamorphopsia in patients suffering from wet AMD before and after Anti VEGF injection; and to match it with OCT results.
This is a single-arm, open-label study where all patients will receive a single injection of SOK583A1 (40 mg/mL) provided in a vial kit at Baseline. The total study duration for the individual participant is approximately 31 days.
This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
The purpose of this study was to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world population intended to be treated with brolucizumab. This study was conducted as part of the post-marketing regulatory commitment to the Indian Health authority.
Age-related macular degeneration (AMD) is a chronic and progressive eye disease and is one of the leading causes of vision impairment globally. AMD is referred to as either the dry or the wet type, where the wet type (also called neovascular-AMD or nAMD) is a later stage of the disease with neovascularization and retinal edema being the main attributes. This will usually cause subacute distortion or loss of central vision in patients. Since 2004, a successful treatment alternative for nAMD has been ocular injections with anti-VEGF (anti-Vascular Endothelial Growth Factor), causing the neovascularization and edema to regress and vision to improve. However, injections have to be repeated, usually requiring 8 injections or more during the first year of treatment. This can cause both a risk for serious adverse effects and is a significant financial drain on health care resources. Patients undergoing treatment are at risk for retinal edema recurrence. The time interval tolerated between injections is individual, and the accepted treatment strategy of today is to gradually, in a stepwise manner, increase the interval between injections. For some patients this extension is well tolerated, but for many patients relapse of proliferations and retinal edema will recur. With state-of-the-art technology OCT-A (optical coherence tomography-angiography) in combination with the clinically, well established examination method of OCT (optical coherence tomography), the project group will study the phenotypic vessel and tissue changes that occur in between injections. Furthermore, the investigators will measure cytokines, chemokines and growth factors in blood samples and the tear film during different treatment stages to see if any single factor is prognostic for poorer response to treatment or relapse. In the short term, the project group hope that the knowledge gained from this project could lead to a better understanding of the mechanisms behind nAMD neovascular relapse and to apply this to routine screening in the clinics. In the longer term, the project group hope that elucidating the physical mechanisms and molecular changes could enable new targeted therapies to be developed. Aim 1: To characterize the phenotype of vessels in relapsing nAMD patients and compare to those without relapse using OCT-A imaging Aim 2: To investigate retinal edema and choroidal thickness in correlation with neovascular changes of relapsing nAMD Aim 3: To measure cytokines, chemokines and growth factors in the tear film before and during treatment with anti-VEGF for nAMD With our main hypothesis being: Relapse of nAMD in patients occurs principally through reconfiguration and vasodilatation of persistent non-regressed vessels following anti-VEGF treatment, while fully regressed vessels remain dormant